Công ty cổ phần GMPc Việt Nam

1. PHARMACEUTICAL INSPECTION CONVENTION
PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME
PE 009-9 (Intro) 1 September 2009
PE 009-9 (Intro)
1 September 2009
GUIDE TO GOOD MANUFACTURING
PRACTICE FOR MEDICINAL PRODUCTS
© PIC/S September 2009
Reproduction prohibited for commercial purposes.
Reproduction for internal use is authorised,
provided that the source is acknowledged.
Editor: PIC/S Secretariat
14 rue du Roveray
CH-1207 Geneva
e-mail: info@picscheme.org
web site: http://www.picscheme.org

2. Introduction
PE 009-9 (Intro) 1 September 2009
INTRODUCTION
General
In order to further facilitate the removal of barriers to trade in medicinal
products, to promote uniformity in licensing decisions and to ensure the maintaining
of high standards of quality assurance in the development, manufacture and control
of medicinal products, the following Guide to Good Manufacturing Practice for
Medicinal Products and its Annexes has been adopted.
The standards set out herein apply to medicines and similar products
intended for human use. It is recommended, however, that the same kind of
attention be given to the manufacture of veterinary products. Administrative
measures of national health authorities should be directed towards the application of
these standards in practice, and any new or amended national regulations for good
manufacturing practice should at least meet their level. These standards are also
intended to serve manufacturers as a basis for the elaboration of specific rules
adapted to their individual needs.
It is recognised that there are acceptable methods, other than those
described in this Guide, which are capable of achieving the principles of the Guide.
This Guide is not intended to place any restraint upon the development of new
concepts or new technologies, which have been validated and provide a level of
Quality Assurance at least equivalent to those set out in this Guide.
The Guide is divided into two parts and a number of annexes which are
common to both parts. Part I covers GMP principles for the manufacture of medicinal
products. Part II covers GMP for active substances used as starting materials. The
annexes provide detail on specific areas of activity. For some manufacturing
processes, different annexes will apply simultaneously (e.g. annex on sterile
preparations and on radiopharmaceuticals and/or on biological medicinal products).
A glossary of some terms used in the Guide has been incorporated after the
annexes. A specific glossary for APIs can be found at the end of Part II.
History
Part I of the PIC/S GMP Guide
Originally, the PIC/S GMP Guide (“PIC Basic Standards” of 1972) derives
from the WHO GMP Guide and was further developed in order to comply with
stringent manufacturing and health requirements in PIC/S countries, to cover new
areas (e.g. biologicals, radiopharmaceuticals, etc.) and to adapt to scientific and
industrial technology (e.g. biotech, parametric release etc.). The aim of such
improvements was to ensure that high quality medicines were produced in line with
the PIC Convention and then the PIC Scheme.
In 1989, the EU adopted its own GMP Guide, which – in terms of GMP
requirements – was equivalent to the PIC/S GMP Guide. Since that time, the EU and
the PIC/S GMP Guides have been developed in parallel and whenever a change has
been made to one, the other has been amended so that both Guides are practically
identical.

3. Introduction
PE 009-9 (Intro) 1 September 2009
There are, however, some differences between the two Guides. These
differences are the following:
the definition of Pharmaceutical Product (referred to as “Medicinal Product” in
this Guide), which is found in Article 1 of the Pharmaceutical Inspection
Convention, has been retained;
references to the EU Directives, as well as to MRAs, have been deleted;
the expression “authorised person” (see Glossary) is used in the PIC/S Guide
while the expression “Qualified Person” is used in the EU Guide;
since not all Participating Authorities under the PIC Scheme are parties to the
European Pharmacopoeia Convention, the mention of “European
Pharmacopoeia” in the Guide has been amended to read “European or other
relevant Pharmacopoeia”.
Part II of the PIC/S GMP Guide
On 22 May 2001, the PIC/S Committee adopted the “Good Manufacturing
Practice Guide for Active Pharmaceutical Ingredients” (ICH Q7A) developed by the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) as a stand-alone guide
(PE 007). It is recalled that the first draft of this GMP Guide for APIs was elaborated
by PIC/S, before it was transferred to ICH. At its Düsseldorf meeting on 29-30 May
2006, the PIC/S Committee decided to make it Part II of the current Guide.
ADOPTION AND ENTRY INTO FORCE
Adoption by the Committee of PE 009-9 6 May 2009
Entry into force of PE 009-9 1 September 2009
REVISION HISTORY
Date Version Number Reasons for revision
21 December 2000 PH 1/97 (Rev.) Revision of Annex 14
Renumbering of all annexes
Change in the editor’s address and
insertion of copyright statement
Inclusion of revision history
10 August 2001 PH 1/97 (Rev. 2) Amendment of para. 42 of Annex 1
Revision of Annex 6
New Annex 15
New Annex 17
Amendment to the glossary

4. Introduction
PE 009-9 (Intro) 1 September 2009
15 January 2002 PH 1/97 (Rev. 3) New Annex 4
New Annex 5
Reference to Annex 18 of EC GMP
Guide
1 September 2003 PE 009-1 Amendment of Annex 1 (mainly
section 3)
1 July 2004 PE 009-2 Revision of Annex 13
Change in the Editor’s co-ordinates
1 January 2006 PE 009-3 Revision of Chapter 1
1 June 2006 PE 009-4 Revision of Chapter 6
1 August 2006 PE 009-5 Corrections to revision of Chapter 6
Revision of Chapter 8
5 April 2007 PE 009-6 Reorganisation of the PIC/S GMP
Guide in Part I, Part II and Annexes
Incorporation of PE 007 (APIs guide)
as Part II
New Annex 19
Revision of the Introduction
Change in the Editor’s co-ordinates
1 September 2007 PE 009-7 Revision of General Introduction
(“History”) and Introduction to Part II
Deletion of footnotes in Chapter 6
(Part I) and Annex 13
15 January 2009 PE 009-8 Revision of Chapter 1 (Part I)
Revision of Annex 1
New Annex 20
1 September 2009 PE 009-9 Revision of Annex 3